At a Glance
- Tasks: Lead global regulatory strategies to ensure safe and effective treatments worldwide.
- Company: Join GSK, a global biopharma company dedicated to improving lives.
- Benefits: Competitive salary, bonuses, health benefits, and flexible working options.
- Why this job: Make a real impact in global healthcare and shape the future of medicine.
- Qualifications: Bachelor's degree in Biological or Healthcare Science with regulatory affairs experience.
- Other info: Dynamic environment with opportunities for career growth and innovation.
The predicted salary is between 120000 - 200000 £ per year.
Are you passionate about making a difference in global healthcare? At GSK, we are dedicated to improving lives by delivering innovative medicines and vaccines. As a Director of Regulatory Affairs, you will play a pivotal role in shaping regulatory strategies that ensure the availability of safe and effective treatments worldwide. Join us and be part of a team committed to creating healthier communities.
Job Purpose
Accountable to GRL and Global Regulatory TA Head, the Director of Regulatory Affairs will lead the development of regional / global regulatory strategies and their execution for assigned asset(s) aligned with the overall Medicines Development Strategy. Planning will be on a multiple‑year horizon, with delivery requiring extensive matrix leadership within GSK to VP level and representing GSK with local regulatory agency. This role works closely with local / regional commercial teams to secure best possible labelling commensurate with the available data and to lead interactions with local / regional regulatory authorities.
Key Responsibilities
- Ensure the regulatory strategy will deliver the needs of the local region(s), considering the needs of other regions globally.
- Implement the regional strategy(s) in support of the project globally.
- Lead regulatory interactions and the review processes in local region.
- Ensure appropriate interaction with regional commercial teams in local region.
- Ensure compliance with regional requirements at all stages of product life.
- Advocate persuasive approaches to senior leaders in GSK and in Health Authorities.
- Capable of providing assessment of potential in license molecules.
Basic Qualifications
- Bachelor's degree in Biological or Healthcare Science, with previous experience in similar strategic international regulatory affairs positions.
- Extensive experience in regulatory affairs across all phases of drug development.
- Proven track record in leading regional development, submission, and approval activities.
- Experience working on clinical trial and licensing requirements in major countries.
Preferred Qualifications
- PhD in Biological or Healthcare Science.
- Experience with projects involving little or no precedence in regulatory affairs.
- Expertise in developing product or therapeutic knowledge in new areas.
- Familiarity with digitalization in regulatory strategy to enhance decision‑making and innovation.
- Proven ability to deliver creative solutions to regulatory challenges while ensuring compliance.
- Exceptional communication and leadership skills, with the ability to build strong networks and influence stakeholders.
If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $166,650 to $277,750. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share‑based long‑term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
Why GSK?
Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Director employer: The Association of Technology, Management and Applied Engineering
Contact Detail:
The Association of Technology, Management and Applied Engineering Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching GSK’s values and recent projects. Tailor your responses to show how your experience aligns with their mission of improving global healthcare. This will help you stand out as a candidate who truly gets what they’re about.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. Focus on articulating your leadership skills and regulatory expertise, as these are key for a Director role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining the GSK team and making a difference in healthcare.
We think you need these skills to ace Director
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Director role. Highlight your experience in regulatory affairs and how it aligns with GSK's mission to improve global healthcare. We want to see how you can make a difference!
Showcase Your Leadership Skills: As a Director, you'll need to demonstrate strong leadership abilities. Share examples of how you've led teams or projects in the past, especially in regulatory settings. We love seeing candidates who can inspire and influence others!
Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language to explain your qualifications and experiences. We appreciate candidates who can communicate effectively, just like we do at StudySmarter!
Apply Through Our Website: Don't forget to submit your application through our official website! It’s the best way for us to receive your details and ensure you’re considered for the role. We can't wait to see what you bring to the table!
How to prepare for a job interview at The Association of Technology, Management and Applied Engineering
✨Know Your Regulatory Landscape
Before the interview, dive deep into GSK's regulatory strategies and recent developments in global healthcare. Familiarise yourself with their therapeutic areas and how they align with your experience. This will help you demonstrate your understanding of the role and how you can contribute to their mission.
✨Showcase Your Leadership Skills
As a Director, you'll need to lead cross-functional teams. Prepare examples of how you've successfully led projects or initiatives in the past, especially those that required collaboration across different regions or departments. Highlight your ability to influence stakeholders and advocate for regulatory strategies.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in regulatory affairs. Think of specific challenges you've faced in previous roles and how you navigated them. Be ready to discuss how you would approach regulatory interactions and compliance issues in various scenarios.
✨Emphasise Your Innovative Mindset
GSK values creativity in overcoming regulatory challenges. Be prepared to discuss any innovative solutions you've implemented in your past roles, particularly those that involved digitalisation or new therapeutic areas. This will show that you're not just compliant but also forward-thinking.